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Sharper Focus On Vaccine: A Huge Scope To Reduce Disease Burden In India

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Several international research studies have conclusively established that the aggressive application of nationally recommended prevention activities could significantly reduce the burden of disease in several areas. Immunization or vaccination program is one such critical areas.

Several ailments, which used to be so common all over the world, can now be effectively prevented through vaccination. The most common and serious vaccine-preventable diseases are: diphtheria, Haemophilus influenzae serotype b (Hib), hepatitis B and C, measles, meningitis, mumps, pertussis, poliomyelitis, rubella, tetanus, tuberculosis, rotavirus, pneumococcal disease and yellow fever.  The list of the World Health Organization (WHO) indicates that vaccines are now available for 25 different diseases.

Thus, vaccination can save millions of lives and morbidity that such diseases still cause to a very large number of global population. Thanks to vaccines, two most scary diseases – small pox (totally) and polio (almost totally), have been eliminated from the world.

No doubt, why vaccination was voted as one of the four most important developments in medicine of the past 150 years, alongside sanitation, antibiotics and anesthesia by readers of the ‘British Medical Journal (BMJ)’ in 2007. It has been decisively proved that vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 3 million deaths every year, throughout the world, topping the list in terms of lives saved.

In tandem, concerted efforts need to be made by both the industry and the Governments to improve affordable access to all these vaccines for a larger section of the population, especially in the developing world.

A crying need still exists:

Nevertheless, there is still a crying need for greater encouragement, more resource deployment and sharper focus towards newer vaccine development for many more dreaded and difficult diseases. One such area is malaria vaccine.

Some areas of new vaccine development:

Following is an example of some newer therapy areas where novel vaccines are now reportedly under development:

  • Malaria vaccine
  • Cancer vaccine
  • AIDS
  • Alzheimer’s disease

Malaria vaccine:

A July 24, 2015 article of the BBC News states, the ‘European Medicines Agency (EMA)’ gave a positive scientific opinion after assessing the safety and effectiveness of the first anti-malarial vaccine of the world – Mosquirix, developed by the British pharma major GlaxoSmithKline.

The vaccine reportedly targets the ‘P. falciparum’, the most prevalent malaria parasite and the deadlier of the two parasites that transmit the disease. At present, in the absence of any licensed vaccines for malaria, the main preventive measures to contain the spread of this parasitic disease are spraying of insecticides, use of other mosquito repellent and mosquito nets.

However, it was observed during its clinical trial that he best protection with this vaccine was achieved among children aged five to 17 months, receiving three doses of the vaccine a month apart, plus a booster dose at 20 months. In this group, cases of severe malaria were cut by a third over a four-year period, the report said.

Some concern was also expressed, as the effectiveness of the vaccine waned over time, making the booster shot essential, without which the vaccine did not cut the rate of severe malaria over the trial period. Moreover, the vaccine did not prove very effective in protecting young babies from severe malaria.

This caused a dilemma for the ‘World Health Organization (WHO)’. On the one hand, the stark reality of malaria killing around 584,000 people a year worldwide, and on the other, lack of conclusiveness in the overall results for this vaccine. Therefore, the world health body decided at that time to further consider about it, soon after the experts’ deliberation on whether to recommend it for children, among whom trials have yielded mixed results, gets completed.

The good news is, on November 18, 2016, Newsweek reported the announcement of the W.H.O, that Mosquirix will be piloted across sub-Saharan Africa in 2018, after a funding approval of US$ 15 million for this purpose.

Cancer vaccines:

According to the National Cancer Institute, which is a part of the National Institutes of Health (NIH) of the United States, cancer vaccines belong to a class of substances known as biological response modifiers. Biological response modifiers work by stimulating or restoring the immune system’s ability to fight infections and disease. There are two broad types of cancer vaccines:

  • Preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people.

-       Persistent infections with high-risk human papillomavirus (HPV) types can cause cervical cancer, anal cancer, oropharyngeal cancer, and vaginal, vulvar, and penile cancers. Three vaccines are approved by the US Food and Drug Administration (FDA) to prevent HPV infection: Gardasil®, Gardasil 9®, and Cervarix®.

-       Chronic Hepatitis B virus (HBV) infection can lead to liver cancer. The FDA has approved multiple vaccines that protect against HBV infection, such as, Engerix-B and Recombivax HB, which protect against HBV infection only.

  • Treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body’s natural immune response against the cancer. Treatment vaccines are a form of immunotherapy.

-       In April 2010, the USFDA approved the first cancer treatment vaccine. This vaccine, sipuleucel-T (Provenge®), is approved for use in some men with metastatic prostate cancer. It is designed to stimulate an immune response to prostatic acid phosphatase (PAP), an antigen that is found on most prostate cancer cells.

Another type of cancer vaccine is currently being developed, known as the Universal Cancer Vaccine.

  • Universal Cancer Vaccine,  June 1, 2016 issue of ‘The Independent’ reported that scientists of Johannes Gutenberg University in Germany have taken a “very positive step” towards creating a universal vaccine against cancer that makes the body’s immune system attack tumors as if they were a virus. The researchers had taken pieces of cancer’s genetic RNA code, put them into tiny nanoparticles of fat and then injected the mixture into the bloodstreams of three patients in the advanced stages of the disease. The patients’ immune systems responded by producing “killer” T-cells designed to attack cancer.

The vaccine was found to be effective in fighting “aggressively growing” tumors in mice. At the same time, such vaccines are fast and inexpensive to produce, and virtually any tumor antigen (a protein attacked by the immune system) can be encoded by RNA, the report said.

The analysts forecast the global cancer vaccines market to grow at a CAGR of 27.24 percent over the period 2014-2019.

HIV/AIDS Vaccine:

The 21st International AIDS Conference (AIDS 2016) held in Durban, South Africa from July 18 to 22, 2016, revealed that a vaccine against HIV will be trialed in South Africa later in 2016, after meeting the criteria needed to prove it, could help fight the epidemic in Africa. A small trial, known as HVTN100, took place in South Africa in 2015 to test the safety and strength of immunity the vaccine could provide, ahead of any large-scale testing in affected populations.

This development reportedly has its origin in a large landmark 2009 trial of RV 144 vaccine in Thailand, demonstrating the proof of concept that a preventive vaccine with a risk reduction of 31 percent could effectively work.  The trial was supported by the World Health Organization (WHO) and UNAIDS. The clinical trial participants who received Vacc-4x, reportedly “experienced a 70 percent viral load decrease relative to their level before starting Anti-Retroviral Therapy (ART), compared with no notable reduction among placebo recipients.”

Alzheimer’s disease vaccine:

A vaccine for Alzheimer’s disease could be trialed in human within the next 3-5 years, after researchers from the United States and Australia have uncovered a formulation that they say successfully targets brain proteins, which play a role in the development and progression of the disease, states a July 18, 2016 report published in the ‘Medical News Today (MNT)’.

This vaccine generates antibodies that target beta-amyloid and tau proteins in the brain – both of which are considered hallmarks of Alzheimer’s disease. In their study, the researchers found that the formulation was effective and well-tolerated in Alzheimer’s mouse models, with no reports of adverse reactions. The vaccine was also able to target the proteins in brain tissue from patients with Alzheimer’s.

Study co-author Prof. Michael Agadjanyan, Institute for Molecular Medicine, California said: “This study suggests that we can immunize patients at the early stages of AD (Alzheimer’s disease), or even healthy people at risk for AD, using our anti-amyloid-beta vaccine, and, if the disease progresses, then vaccinate with another anti-tau vaccine to increase effectiveness.”

If the vaccine continues to show success in these preclinical trials, the researchers envisage that they could be testing the vaccine in individuals at high risk for Alzheimer’s, or those in the early stages of the disease, within the next 3-5 years.

More details on vaccine development:

A 2012 report on vaccines, published by the Pharmaceutical Research and Manufacturers of America (PhRMA) give details of vaccines under development.

Vaccine requirements of the developing world: 

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus, to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

Issues and challenges:

To produce a safe, effective and marketable vaccine, besides R&D costs, it takes reportedly around 12 to 15 years of painstaking research and development process.

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines, and then for the distribution of the same mostly using cold-chains.

Around 60 percent of the production costs of vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus, such products will need to have a decent market size to be profitable. Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will mostly be required for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non-Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. Thus, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

India needs a vibrant vaccine business sector:

For a greater focus on all important disease prevention initiatives, there is a need to build a vibrant vaccine business sector in India. To achieve this objective the government should create an enabling ecosystem for the vaccine manufacturers and the academics to work in unison. At the same time, the state funded vaccine R&D centers should be encouraged to concentrate more on the relevant vaccine development projects, ensuring a decent return on their investments for long-term economic sustainability.

Often, these stakeholders find it difficult to deploy sufficient fund to take their vaccine projects successfully through various stages of clinical development to obtain marketing approval from the drug regulator, while earning a decent return on investments. This critical issue needs to be urgently addressed by the Government to make the disease prevention initiatives in the country sustainable.

A possible threat to overcome: 

As per reports, most Indian vaccine manufacturers get a major chunk of their sales revenue from exports to UN agencies, charitable organizations like, the Bill & Melinda Gates Foundation, GAVI, and other country-specific immunization programs.

The report predicts, the virtual monopoly that Indian vaccine manufacturers have enjoyed in these areas, will now be challenged by China, as for the first time in 2012, the Chinese national regulatory authority received ‘pre-qualification’ certification of WHO that allows it to approve locally manufactured vaccines to compete for UN tenders.

Conclusion:

Keeping this in perspective, vaccine related pragmatic policy measures need to be taken in the country for effective disease prevention, covering all recommended age groups, of course, with an equal focus on their effective implementation, without delay. Consequently, this will not only help reduce the disease burden in the country, but also provide the much-awaited growth momentum to the vaccine market in India.

Alongside, increasing number of modern imported vaccines coming in, would help India address one of its key healthcare concerns effectively, and in a holistic way.

It is about time to aggressively garner adequate resources to develop more modern vaccines in the country. In tandem, a rejuvenated thrust to effectively promote and implement vaccine awareness campaigns, would help immensely in the nation’s endeavor for disease prevention with vaccines, that offers a huge scope to reduce disease burden, for a healthier India.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Immunization Still Remains A Low-Budget Neglected Area In India

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Although India is a leading producer and exporter of vaccines, the country has the greatest number of deaths among children under 5, and the majority are from vaccine-preventable diseases. Less than 44 percent of India’s young children receive the full schedule of immunizations, commented a research study of Michigan University of the United States.

This is noteworthy, as vaccines are one of the most successful and cost-effective public health interventions. The World Health Organization (WHO) defines vaccines as:

“A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines include, for example, suspensions of killed or attenuated microorganisms, or products or derivatives of microorganisms. The most common method of administering vaccines is by injection, but some are given by mouth or nasal spray.”

Vaccines help prevent over two to three million children each year. However, another 1.5 million children still die from diseases that could be prevented by routine vaccines, as estimated by the WHO.

“The developing world should no longer experience 450,000 preventable deaths each year from rotavirus, nor 145,000 from measles. By the same token, there should no longer be 2000 preventable deaths each year from influenza in Australia. It is time to use our global health efforts to address the most pressing risks, both at home and abroad,” expects another article published in the Volume 45, No.1, January-February 2016 edition of the journal of ‘Australian Family Physician (afp)’

Nevertheless, the bottom line is, an estimated 19.4 million infants worldwide is still missing out on basic vaccines, which otherwise come rather easily to the children of the developed nations of the world, as per the ‘Fact Sheet’ of the World Health Organization (W.H.O) of September 2016.

A commendable global initiative:

To resolve this inequity, in January 2000, the Global Alliance for Vaccines and Immunization (GAVI) was formed. This initiative was mainly aimed at generating sufficient fund to ensure availability of vaccines for children living in the 70 poorest countries of the world.

The GAVI Alliance has been instrumental in improving access to six common infant vaccines, including those for hepatitis B and yellow fever. GAVI is also working to introduce pneumococcal, rotavirus, human papilloma virus, meningococcal, rubella and typhoid vaccines in not too distant future.

Current ground situation in India:

In this area, the prevailing situation in India is much worse.

The Global consulting major – McKinsey in its report titled, “India Pharma 2020: Propelling access and acceptance, realizing true potential” stated that at 2 percent penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million, where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1.7 billion by 2020.

Some of the important reasons for poor penetration of the vaccine market in India can be found in a March 02, 2016 research article published in the ‘Michigan News’ of the University of Michigan. The paper articulated some important facts, as follows:

  • Out of 26 million children born in India every year, two-thirds of them do not receive their vaccinations on time, prolonging their susceptibility to diseases and contributing to untimely deaths.
  • Only 18 percent of children are vaccinated with the recommended three doses of DPT vaccine.
  • Only 12 percent of children are vaccinated with the measles vaccine by the required age of 9 months, although 75 percent are vaccinated by age 5. This delay in vaccination can contribute to frequent outbreaks of measles in India.
  • India is adding vast numbers of new children who need vaccination, while the older ones remain under or unvaccinated because of immunization delays, is like “walking too slowly on a moving treadmill – you continually fall further back.”
  • India hopes to add rotavirus to its Universal Immunization Program, a free government-approved vaccination program that was looked at in this study.
  • The government has the infrastructure to deliver vaccines, but the motivations for delivering all vaccination doses decreases over time.
  • India hopes to add rotavirus to its Universal Immunization Program, a free government-approved vaccination program that was looked at in this study.

Needs both policy and budgetary support:

As stated above, the overall immunization scenario in India, as on date, is rather grim. Besides, in view of the humongous disease burden of India, immunization program with various types of vaccines should receive active encouragement from the government as disease prevention initiatives, at least, keeping the future generation in mind. In the next Union Budget of India, this issue should attract fresh policy measures, spearheaded by the Central Government, with requisite fund allocation both by the Central and State Governments.

Low immunization budget and other key barriers:

‘Health Affairs’ – a leading peer-reviewed journal on health policy thought and research, highlighted that India spends woefully little on routine immunization. Quoting data published by the Union Ministry of Health the report stated, only 2.1 percent of the national government’s health budget is allocated to routine immunization – a small amount given the country’s large population and the number of births. Although vaccines used in India are primarily provided free and through the government channels, over 30 percent of the population still purchase vaccines from the private market as a part of their out of pocket expenses.

Besides, there is a long list of other challenges to India’s immunization program. These include a shortage of trained personnel to manage the program at both the national and state levels; the need to undertake innovations in vaccines, disease surveillance, vaccine procurement, and effective vaccine management; the absence of good data on disease burden to inform vaccination priorities; the lack of baseline surveillance data for monitoring the effects of vaccination; and the absence of a system of routine reporting and surveillance, the report stated.

Everyone in the country is expected to fulfill the individual responsibility to get their own children properly vaccinated by properly following, and completing the vaccination schedule. Better all-round and ongoing communication of the long-term benefits of vaccination for many serious disease prevention against negligible side effects, could create greater awareness for compliance.

Indian vaccine market and the key local players:

A report titled ‘Vaccines Market in India 2013’, published by Netherlands Office of Science & Technology, New Delhi, estimated that vaccines contributed largest share in the total Biopharma sales with estimated sales of US$ 602 million in FY 2011-12 over US$ 417.5 million of the previous year. Over half of the top 10 firms in the industry are active in the private sector vaccines market has recorded a growth of about 25 percent.

India is not just a leading producer and exporter of vaccines, it develops and markets complex vaccines, such as, pentavalent rotavirus vaccine. There are around 13 major vaccine manufacturers in India. Companies like, Serum Institute, Shantha Biotecnics, Bharat Biotech and Panacea Biotech are taking commendable strides in this direction. Bharat Biotech is incidentally the largest Hepatitis B vaccine producer in the world.

Around 43 percent of the global Universal Immunization Program vaccine supply (more than 70 percent in the case of single vaccine) reportedly comes from India. Indian vaccine major Serum Institute is reportedly one of the largest suppliers of vaccines to over a 130 countries of the world and claim that ’1 out of every 2 children immunized worldwide gets at least one vaccine produced by Serum Institute.’

Expand Government immunization product spectrum:

It is high time for the Union Ministry of Health to expand the product spectrum for vaccines, as an integral part of its disease prevention program. It is recommended that the routine immunization program of India should now include other important vaccines, such as, Haemophilus influenzae type b, hepatitis B, and rotavirus, as recommended by the National Technical Advisory Board (DTAB) on Immunization.

Conclusion:

Against this backdrop, a holistic immunization program can no longer remain a low-budget and virtually neglected area in India.

Effective resolution of this important issue by the Government would require both the Union and the State Governments to increase their respective budget significantly. It would help launching a well-integrated multi-pronged approach to include most of the remaining one third of the population in the state-run immunization program.

In tandem a strategic pathway needs to be crafted to expand the immunization product spectrum, increase awareness to encourage more household to take part in the holistic immunization initiatives for disease prevention, and counter the anti-vaccine advocates effectively. There is also an urgent need to make more investments in disease surveillance. An integrated approach towards all these initiatives would significantly help reduce the overall burden of disease in the country.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Vaccines Development: Is it Just a Business Based on Fear?

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‘Vaccination – A Business based on fear’, is the title of a book written by Dr. Gerhard Buchwald M.D, a German medical doctor and a vaccination critic. This book talks about:

“The damage and the deaths caused by vaccination are written off as ‘pure coincidence’, as something which would have occurred anyway, even without vaccination. Often damage is trivialized by claiming that vaccine damage occurs only very, very rarely, or the damage is covered up by naming as the cause, the most unlikely syndromes which can only be found in special literature.”

However, his critics and pro-vaccination experts do opine that this book “is a pathetic presentation of vaccination, from a self-proclaimed anti-vaccination lobbyist. It is full of half-truths, blatant lies and misrepresented statistics”.

Vaccination – one of the most important development in medicines: 

Quite in contrary to what Dr. Gerhard Buchwald wrote, vaccination was voted as one of the four most important developments in medicine of the past 150 years, alongside sanitation, antibiotics and anesthesia by readers of the ‘British Medical Journal’ in 2007. No wonder, Vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 3 million deaths every year throughout the world topping the list in terms of lives saved.

Vaccines that are being developed and marketed today, though provide high level of protection against increasing number of diseases with reduction of associated morbidity and mortality, there is still a crying need for greater encouragement, more resource deployment and sharper focus towards newer vaccines development for many more dreaded and difficult diseases.

In tandem, concerted efforts need to be made by both the industry and the government to improve affordable access to all these vaccines for a larger section of the population, especially in the developing world.

Rejuvenating trend:

However, from the business perspective, the vaccine market, though initially considered to be a low-profit initiative, now has started being under rejuvenated focus keeping pace with improved understanding of the human immune system. The future scope of vaccines is immense, as the management of several potentially preventable diseases remains still unaddressed.

Consequently, the focus of the global vaccine industry is getting expanded from prophylactic vaccination for communicable disease (e.g. DTP vaccine) to therapeutic vaccines (e.g. Anti-cancer vaccines) and then possibly non-communicable disease vaccines (e.g. vaccines for coronary artery disease).

Shifting focus on vaccines types:

As per the ‘National Institute of Health (NIH)’ of USA, following are some types of vaccines that researchers usually work on:

  • Live, attenuated vaccines
  • Inactivated vaccines
  • Subunit vaccines
  • Toxoid vaccines
  • Conjugate vaccines
  • DNA vaccines
  • Recombinant vector vaccines

Among all these segments, sub-unit vaccine is the largest revenue generator, though synthetic vaccines, recombinant vector vaccines, and DNA vaccines are emerging as the fastest-growing segments.

The first vaccine of the world:

In 1796, Edward Anthony Jenner not only discovered the process of vaccination, alongside developed the first vaccine of the world for mankind – smallpox vaccine. To develop this vaccine Jenner acted upon the observation that milkmaids who caught the cowpox virus did not catch smallpox.

As per published data prior to his discovery the mortality rate for smallpox was as high as up to 35%. Thus, Jenner is very often referred to as the “Father of Immunology”, whose pioneering work has “saved more lives than the work of any other person.”

Later on in 1901 Emil Von Behring received the first Nobel Prize (ever) for discovering Diphtheria serum therapy.

R&D costs for vaccines:

According to a paper published by the US National Library of Medicine and National Institute of Health (NIH):

“A vaccine candidate entering pre-clinical development in 2011 would be expected to achieve licensure in 2022; all costs are reported in 2022 Canadian dollars (CAD). After applying a 9% cost of capital, the capitalized total R&D expenditure amounts to $ 474.88 million CAD.”

Issues and challenges:

To produce a safe and effective marketable vaccine, besides R&D costs, it takes reportedly around 12 to 15 years of painstaking research and development process.

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines and then for the distribution of the same mostly using cold-chains.

Around 60% of the production costs for vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus such products will need to have a decent market size to be profitable.

Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will mostly be required for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. As a result, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

A great initiative called GAVI: 

Around 23 million children of the developing countries are still denied of important and life-saving vaccines, which otherwise come rather easily to the children of the developed nations of the world.

To resolve this inequity, in January 2000, the Global Alliance for Vaccines and Immunization (GAVI) was formed. This initiative was mainly aimed at generating sufficient fund to ensure availability of vaccines for children living in the 70 poorest countries of the world.

The GAVI Alliance has been instrumental in improving access to six common infant vaccines, including those for hepatitis B and yellow fever. GAVI is also working to introduce pneumococcal, rotavirus, human papilloma virus, meningococcal, rubella and typhoid vaccines in not too distant future.

In August 2013, GAVI has reportedly launched a campaign in Kenya to fight the world’s leading killer of children under five with a new Pneumococcal Vaccine for prevention from pneumonia, meningitis and sepsis, which kill more than half a million people a year.

GAVI hopes to avert 700,000 deaths by 2015 through the immunization of 90 million children with pneumococcal vaccines.

Global pharma majors Pfizer and GlaxoSmithKline (GSK) are producing the vaccines as a part of a deal part-funded by Britain, Italy, Canada, Russia, Norway and the Bill Melinda Gates Foundation.

Current trend in newer vaccine development:

Malaria Vaccine:

According to the National Institute of Health (NIH) of the United States, the results of an early-stage clinical trial published in August 8, 2013 in the ‘Journal Science’ for an investigational malaria vaccine has been found to be safe to generate an immune system response and to offer protection against malaria infection in healthy adults.

The scientists at Sanaria Inc., of Rockville, Md. Research Center developed this vaccine known as PfSPZ. The researchers reportedly found that injecting patients with live-but-weakened malaria causing parasites appeared to create a protective effect.

Earlier, Reuters on December 20, 2011 reported that the British scientists have developed an experimental malaria vaccine, which has the potential to neutralize all strains of the most deadly species of malaria parasite.

In October 2011, the data published for a large clinical trial conducted in Africa by GlaxoSmithKline on their experimental malaria vaccine revealed that the risk of children getting malaria had halved with this vaccine. Reuters also reported that other teams of researchers around the world are now working on different approaches to develop a malaria vaccine.

Tuberculosis vaccines:

The Lancet reported in March 2013, as BCG vaccination provides incomplete protection against tuberculosis in infants, a new vaccine, modified Vaccinia Ankara virus expressing antigen 85A (MVA85A), has been designed to enhance the protective efficacy of BCG. MVA85A was found well-tolerated and induced modest cell-mediated immune responses. However, the reasons for the absence of MVA85A efficacy against tuberculosis or M tuberculosis infection in infants would need exploration.

Universal Cancer vaccines:

In a breakthrough development, the Israeli company Vaxil BioTherapeutics has reportedly formulated a therapeutic cancer vaccine, now in clinical trials at Hadassah University Medical Center in Jerusalem.

If everything falls in place, the vaccine could be available about six years down the road, to administer on a regular basis not only to help treating cancer but also to keep the disease from recurring.

Though the vaccine is being tested against a type of blood cancer called multiple myeloma, if it works as the initial results indicate, its platform technology VaxHit could be applied to 90 percent of all known cancers, including prostate and breast cancer, solid and non-solid tumors.

HIV Vaccine:

A recent effort to find a vaccine for HIV is reportedly beginning in 2013 at laboratories in a London hospital and two centers in Africa. The work will be split equally between London, the Rwandan capital Kigali and Nairobi in Kenya.

It has been reported that scientists are recruiting 64 healthy adult volunteers for the trial, which is expected to take up to two years.

Vaccines requirements of the developing world: 

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

India needs a vibrant vaccine business sector:

For greater focus on all important disease prevention initiatives, there is a need to build a vibrant vaccine business sector in India. To achieve this objective the government should create an enabling ecosystem for the vaccine manufacturers and the academics to work in unison. At the same time, the state funded vaccine R&D centers should be encouraged to concentrate more on the relevant vaccine development projects ensuring a decent return on their investments, for longer-term economic sustainability.

More often than not, these stakeholders find it difficult to deploy sufficient fund to take their vaccines projects successfully through various stages of clinical development in order to obtain marketing approval from the drug regulator, while registering a decent return on investments. This critical issue needs to be appropriately and urgently addressed by the Government to make the disease prevention initiatives in the country sustainable.

Changing market dynamics: 

Even in a couple of decades back, ‘Vaccines Market’ in India did not use to be considered as a focus area by many pharmaceutical companies. Commoditization of this market with low profit margin and unpredictable interest of the government/the doctors towards immunization were the main reasons. Large global players like Glaxo exited the vaccine market at that time by withdrawing products like, Tetanus Toxoid, Triple Antigen and other vaccines from the market.

Currently, the above scenario is fast changing. The vaccine market, as stated above, is getting rejuvenated not only with the National Immunization Program (NIP) of the country, but also with the emergence of newer domestic vaccines players and introduction of novel vaccines by the global players, which we shall discuss below.

In addition, the ‘Indian Academy of Pediatrics (IAP) Committee on Immunization’ now recommends the ‘best individual practices schedule’ for the children in consultation with their respective parents. Such schedule may not conform to NIP and include newer vaccines, broadening the scope of use of vaccines in general.

Global Market:

According to GBI Research Report, overall global vaccines market was valued at US$ 28 billion in 2010 and is expected to reach US$ 56.7 billion by 2017 with a CAGR of 11.5%. The key growth driver of this segment will be introduction of newer vaccines, which are currently either in the regulatory filing stage or in the late stages of clinical development.

The important international players in the vaccines market are GlaxoSmithKline, Sanofi, Pfizer, Novartis AG, Merck and SP-MSD. Together they represent around 88% of the total vaccine segment globally, the report highlights.

Indian Market:

McKinsey in its report titled, “India Pharma 2020: Propelling access and acceptance, realizing true potential“ stated that at 2% penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million, where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1.7 billion by 2020.

India is one of largest markets for all types of vaccines in the world. The new generation and combination vaccines, like DPT with Hepatitis B, Hepatitis A and Injectable polio vaccine, are driving the growth. The demand for veterinary vaccines is also showing ascending trend. Pediatric vaccines contribute to around 60% of the total vaccines market in India.

Domestic Indian players like, Serum Institute, Shantha Biotecnics, Bharat Biotech and Panacea Biotech are poised to take greater strides in this direction. Bharat Biotech is incidentally the largest Hepatitis B vaccine producer in the world. Likewise, Serum Institute is reportedly one of the largest suppliers of vaccines to over 130 countries and claim that ’1 out of every 2 children immunized worldwide gets at least one vaccine produced by Serum Institute.’

The first new vaccine developed in India:

Indian scientists from Bharat Biotech Ltd in Hyderabad have reportedly developed a new oral vaccine against the Rotavirus induced diarrhea, where both vomiting and loose motion can severely dehydrate children very quickly. This is the first new vaccine developed in India, establishing itself as the first developing country to achieve this unique distinction.

Two recent vaccine JV and Partnership agreements in India:

British drug major GlaxoSmithKline (GSK) has reportedly agreed to form a 50-50 venture with the domestic Indian vaccine manufacturer Biological E Limited in January 2013 to develop a product that would combine GSK’s injectable polio shot with a vaccine produced by Biological E to protect against five diseases including diphtheria and tetanus.

In addition, MSD pharma of the United States and Indian drug major Lupin have announced a partnership agreement to market, promote and distribute, MSD’s 23-valent Pneumococcal Polysaccharide Vaccines under a different brand name in India for prevention of Pneumococcal disease, pneumonia being its most common form affecting adults.

A possible threat: 

As per reports most Indian vaccines manufacturers get a major chunk of their sales revenue from exports to UN agencies, charitable organizations like, the Bill & Melinda Gates Foundation and GAVI, and other country-specific immunization programs.

The report predicts, the virtual monopoly that Indian vaccines manufacturers have enjoyed in these areas, will now be challenged by China, as for the first time, in 2012, the Chinese national regulatory authority received World Health Organization’s (WHO) ‘pre-qualification’ certification that allows it to approve locally manufactured vaccines to compete for UN tenders. 

Action areas to drive growth:

McKinsey in its above report ‘India Pharma 2020’ indicated that the action in the following 4 areas by the vaccine players would drive the vaccine market growth in India:

  • Companies need to go for local production of vaccines or leverage supply partnerships. MSD and GlaxoSmithKline’s local partnership in India and for the HiB vaccine with Bio-manguinhos in Brazil may be cited as examples.
  • Companies will need to conduct studies on the economic impact of vaccination and establish vaccine safety and performance standards.
  • Extension of vaccine coverage beyond pediatricians and inclusion of general practitioners, consulting physicians and gynecologists will be essential.
  • Companies will need to enhance supply chain reliability and reduce costs.

Conclusion: 

On January 7, 2012, while requesting the ‘Overseas Indian Medical Professionals’ to partner with the institutions in India, the Health Minister, in his address, announced that the Ministry of Health has already introduced the second dose of measles vaccine and Hepatitis-B vaccination across the country. Moreover, from December 2011 a ‘Pentavalent Vaccine’ has been introduced, initially in 2 States, covering 1.5 million children of India.

All these augur quite well for the country. However, keeping in view of the humongous disease burden of India, immunization program with various types of vaccines should receive active encouragement from the government as disease prevention initiatives, keeping the future generation in mind.

If vaccine related pragmatic policy measures, with equal focus on their effective implementation, are initiated in the country, without delay, the domestic vaccine market, in turn, will receive much awaited further growth momentum. Such initiatives together with newer foreign players and modern imported vaccines coming in, would help the country addressing effectively a prime healthcare concern of the country in a holistic way.

It is about time to aggressively garner adequate resources to develop more modern vaccines in the country, promote and implement vaccine awareness campaigns in the nation’s endeavor for disease prevention before they strike hard and at times fatally.

That said, taking available real world facts into account, doesn’t Dr. Gerhard Buchwald’s and today’s anti-vaccination lobbyists’ postulation, ‘Vaccination – A Business based on fear’, appear to be emanating from a self created world of doom and gloom, defying public health interest for effective disease prevention?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.